Kornimate/medical-research-clean huggingface dataset:
acupuncture for pain relief during perineal repair after childbirth

Conditions: Birth Injuries; Lacerations; Pain

Summary: midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. the investigators wish to determine whether acupuncture can be used as pain relief during the repair of lacerations in the female pelvic floor following childbirth. three acupuncture points in the ear have been reported highly effective for perineal pain relief. a scientific trial will compare acupuncture with traditional local anaesthetics when midwives conduct perineal repair just after delivery in the hospitals of southern denmark.

a randomised trial has been initiated. 226 healthy primipara are invited to participate if they deliver a child after gestation week 36 and sustain a perineal laceration or an episiotomy during childbirth. the randomisation is done using a computer-controlled voice response system and the compared treatments are: a: acupuncture in shen men, gv20, bl36 and 2 needles in the upper ear. b: local anaesthetics (lidocaine 10 ml/mg) directly in the wound area. primary outcomes are: 1. need for additional pain relief during the perineal repair. 2. pain experienced during perineal repair reported 1 day after delivery. 3. wound healing evaluated 1 and 14 days after delivery. 4. patient satisfaction with the given pain relief.

Eligibility criteria:
inclusion criteria: * primipara * healthy mother and child * danish speaking * perineal laceration or episiotomy that can be sutured by a midwife. exclusion criteria: * large perineal lacerations * heavy bleeding after childbirth * no need for pain relief

Keywords: perineal repair episiotomies midwives pain relief episiotomy
minimal vitrectomy surgery for epiretinal membrane

Conditions: Epiretinal Membrane; Macular Edema (ME); Nuclear Cataract

Summary: this multicenter randomized controlled trial evaluates minimal vitrectomy surgery (mvs) versus conventional vitrectomy for idiopathic epiretinal membrane (erm). the primary endpoints include visual acuity improvement and cataract progression after 12 months. mvs aims to minimize vitreous removal while ensuring complete membrane removal through adaptive limited vitrectomy.

idiopathic epiretinal membrane (erm) is characterized by fibrocellular proliferation on the retinal surface, leading to macular edema, metamorphopsia, and visual impairment. traditional treatment involves pars plana vitrectomy (ppv) with posterior vitreous detachment (pvd) induction and core vitrectomy, which may increase the risk of postoperative cataract. minimal vitrectomy surgery (mvs) is a modified surgical approach designed to minimize vitreous removal and preserve the hyaloid. the epiretinal membrane is directly peeled through the intact vitreous. if pre-existing vitreous floaters or membrane fragments remain after peeling and cannot be removed safely with micro-forceps, limited localized vitrectomy is selectively performed to eliminate these floaters and avoid postoperative visual disturbances. this trial aims to evaluate the efficacy and safety of mvs compared to conventional vitrectomy, focusing on visual improvement, macular thickness, cataract progression, erm recurrence, and intraoperative complications.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. diagnosis of idiopathic epiretinal membrane (erm) confirmed by clinical examination and oct imaging. 3. clear ocular media allowing adequate fundus imaging. 4. phakic eye. 5. ability and willingness to provide written informed consent. exclusion criteria: 1. prior cataract surgery or advanced cataract requiring combined surgery. co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion). 2. systemic conditions preventing safe surgery or follow-up. 3. history of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.

Keywords: idiopathic epiretinal membrane (erm) minimal vitrectomy surgery (mvs) nonvitrectomizing vitreous surgery (nvs) pars plana vitrectomy (ppv)
helping hypertensive latinos to improve medication adherence

Conditions: Hypertension

Summary: poor medication adherence is a major contributor to inadequate bp control, and is associated with 125,000 deaths annually. translation of adherence interventions to community-based primary care practices where majority of latino patients receive care is non-existent. thus, the development of tailored interventions targeted at improving medication adherence in the latino population is needed in order to address the racial disparities in bp control between latinos and whites. this proposal provides a unique opportunity to address this gap in the literature. using a randomized control design (rct), the study will evaluate the effect of a culturally tailored, practice-based intervention on medication adherence in 148 high-risk latino patients with uncontrolled htn. to facilitate translation into routine practices, the intervention will be integrated into the clinic's electronic medical record (emr) system, and will be delivered by trained, bilingual health coaches.

latinos are the fastest growing ethnic group of the u.s. with a growth rate of 43% compared to 23% among whites over the past decade. this increase is four times the nation's 9.7% growth rate, and accounts for more than half of the total u.s. population increase of 27.3 million during this period. this growth is accompanied by a significant increase in cardiovascular disease (cvd)-related morbidity and mortality. despite increasing trends in the awareness and treatment of hypertension (htn) among all groups, latinos have the lowest blood pressure (bp) control rates in the u.s. although barriers to optimal htn control such as poor access, and low awareness have been used to explain the disparities in bp control between latinos and whites, bp control rates remain lower among latinos who receive treatment compared to whites. this enigma may be explained by the disproportionately poorer adherence to prescribed antihypertensive medications among latinos compared to whites. poor medication adherence is a major contributor to inadequate bp control, and is associated with 125,000 deaths annually. despite over 30 years of research dedicated to understanding adherence behaviors in hypertensive patients, data in latino patients is scant. more importantly, translation of adherence interventions to community-based primary care practices where majority of latino patients receive care is non-existent.

Eligibility criteria:
inclusion criteria: * have uncontrolled hypertension defined as bp\>140/90 mmhg on at least two consecutive visits in the past year (or bp\>130/80 mmhg for those with diabetes or kidney disease) * framingham risk scores (frs) \>20% (or at least one cvd risk factor including hyperlipidemia or diabetes) * be taking at least one antihypertensive medication; * self-identify as latino exclusion criteria: * refuse or are unable to provide informed consent; * currently participate in another hypertension study; * have significant psychiatric comorbidity

Keywords: latino
aphp plateform of normothermic perfusion for rehabilitation of hepatic grafts

Conditions: Liver Diseases

Summary: this study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. grafts have to be allocated to one of 3 liver transplantation centres of paris. after evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time \> 6 months.

in this study, the coordinator investigator proposes to build a platform for perfusing in normothermic conditions all grafts with histologically proven macrosteatosis ≥ 30% that will be considered as unsuitable for upfront lt. these grafts have to be alloacted to one of the 3 liver transplantation centers of assistance publique des hôpitaux de paris. eligible grafts (macrosteatosis ≥ 30%, no severe fibrosis or cirrhosis) will be shipped to the platform for normothermic perfusion. perfusion will be started provided that cold ischemia time do not exceed 8 hours. parameters of grafts viability (lactates, bile production, flow) will be monitored. after a minimum of 4 hours of normothermic perfusion (not exceeding 16 hours), grafts fulfilling strict criteria (homogeneous aspect of the liver without any necrotic regions, lactates \ 7.3, arterial flow \> 150 ml/min and portal flow \> 500 ml/min, homogeneous perfusion of the graft) will be considered suitable for transplantation. recipient will be transferred to the operating room, and first phase of lt (i.e, laparotomy and total hepatectomy) will be started. simultaneously, grafts will be shipped to the center of initial allocation. perfusion will be pursued during the transport from the platform to the recipient. recipients (≥18 years and ≤ 70 years) have to be enlisted for lt with an estimated waiting time \> 6 months (i.e., meld score \< 25) and who signed an informed consent.

Eligibility criteria:
inclusion criteria: * patients enlisted for liver transplantation for liver disease or hcc (afp score≤ 2); * ongoing cotraception in women of reproductive age ; * patient with social security ; * informed signed consent exclusion criteria: * extra-hepatic tumor disease; * re-transplantation ; * pregnancy or brest-feeding; * patients participting in another study; * patients under psychiatric treatment; * patients under tutorship or curatorship

Keywords: steatotic liver graft liver transplantation normothermic perfusion
an experimental study to compare treatment response and toxicities of concurrent chemoradiation with weekly cisplatin and three weekly cisplatin in locally advanced head and neck cancer.

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the aim of this study is to compare treatment responses and toxicities of concurrent chemo-radiation with weekly and three weekly cisplatin in locally advanced head \& neck cancer. half of the participants received cisplatin (40 mg/m2) weekly with radiotherapy, while the other half received cisplatin (100 mg/m2) thrice weekly with radiotherapy. radiotherapy continued five days per week for six and half weeks.


Eligibility criteria:
inclusion criteria: * biopsy proved, previously untreated, squamous cell carcinoma of head \& neck * stages iii to ivb exclusion criteria: * patients with history of prior chemotherapy or radiotherapy to the head and neck region. * initial surgery (excluding diagnostic biopsy) of the primary site. * patients with synchronous primaries. * those who are not willing to be included in the study. * pregnant or lactating woman. * serious medical illness * prisoners.

Keywords: locally advanced head and neck cancer concurrent weekly cisplatin three weekly cisplatin radiotherapy
tight glycemic control in acute exacerbations of copd

Conditions: COPD; Hyperglycemia

Summary: glucose control has been shown as an important and independent prognostic factor in several acute conditions in hospitalized patients, including acute mi, stroke, cardiac surgery and in critical care units. patients with acute exacerbation of copd (aecopd)and diabetes treated with insulin had a longer in-patient stay and more frequent isolation of gram negative bacteria from sputum than those without diabetes.hyperglycemia (\>11 mmol/l) on admission predicted failure of non-invasive ventilation and infectious pulmonary complications in patients admitted to the icu with acute respiratory failure caused by severe aecopd. the primary goal of this study is to test the hypothesis that in aecopd, tight glycemic control during hospital stay will improve outcome of hospitalization. the secondary goal of this study is to test new ways in controlling patients in the internal medicine ward.


Eligibility criteria:
inclusion criteria: * current or past smokers (at least 20 py) * patient with copd be ats criteria * hospitalized with acute exacerbation, 2/3 criteria:1- worsening of sob 2-change in sputum volume 3- change in sputum color * signed informed concent exclusion criteria: * respiratory failure (ph\ 60 ) * pneumonia * pneumothorax * bronchiectasis * lung collapse * congestive heart failure * lung cancer * suspected pulmonary emboli * immune deficiency (acquired 0r congenital) * cystic fibrosis * post lung implantation * asthma/ non smokers

Keywords: inpatients with copd glucose control
sphere hypertension baseline data study

Conditions: Hypertension

Summary: we are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an emt.

we are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an emt. we want to understand what these patients currently remember occurring during the 9-1-1 response around their high blood pressure measure; if the patients seek a second reading; if the patients seek follow-up care as a result of the high blood pressure measure. we are also interested if patients trust emts as a provider of preventive health care. this baseline data will also allow us to more accurately measure the success of a future intervention study aimed at motivating subjects to receive a follow-up hypertension assessment from a physician after receiving a high blood pressure reading from an emt.

Eligibility criteria:
inclusion criteria: * systolic blood pressure greater than or equal to 160 and/or diastolic blood pressure greater than or equal to 100 * patient is at least 18 years old * patient was not transported by paramedics * patient was not admitted to a hospital * patient is not a nursing home/adult family home resident * patient's phone number is listed in the mirf database exclusion criteria: * not meeting inclusion criteria
study of placental inflammation in gestational diabetes

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: the aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome nlrp3 and the chemokine scavenger decoy receptor d6

the aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome nlrp3 and the chemokine scavenger decoy receptor d6, compared to women with uncomplicated pregnancy

Eligibility criteria:
inclusion criteria: * women with gestational diabetes mellitus * women with uncomplicated pregnancy * age \>18 years * singleton pregnancy exclusion criteria: * age \< 18 years * infections (hiv,hcv) * multiple pregnancy * cancer
neurobiology of opioid dependence: 5 - 5

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.


Eligibility criteria:
please contact site for information.
biomarkers of synaptic damage in multiple sclerosis

Conditions: Multiple Sclerosis; Parkinson Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease

Summary: a prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the neuromed neurology unit. subjects with other chronic neurodegenerative diseases such as amyotrophic lateral sclerosis (als), alzheimer's disease (ad) and parkinson's disease (pd), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited as control groups.

blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. subsequently, the levels of micrornas, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (objective 1) will be determined. furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of ms, using the patch-clamp technique (objective 2). genotyping studies will be conducted in order to identify single nucleotide polymorphisms (snps) in coding and / or regulating regions of genes (micrornas or proteins) involved in alterations of the synaptic transmission of ms and its murine experimental model (i.e. slc1a3, ngfb, pdgfa, etc.), which correlate with specific clinical parameters (i.e. edss, brems, disease progression index, ms type, disease activity, etc.) and with the levels of potential biomarkers identified

Eligibility criteria:
inclusion criteria: 1. male and female patients (age between 18 and 65 years) 2. diagnosis of ms in accordance with mcdonald's (2010 rev) criteria, 3. edss between 0 and 5.5 (included), 4. patients able to provide informed consent to participation in the study exclusion criteria: 1. inability to provide informed written consent 2. altered basal blood count 3. pregnancy or lactation 4. contraindications for the execution of magnetic resonance imaging with gadolinium 5. significant clinical conditions in addition to sm or other chronic neurodegenerative diseases including latent viral infections

Keywords: synaptic plasticity neuroinflammation neurodegeneration
investigating the effects of beta-hydroxy-beta-methylbutyrate on glucose handling in older and younger men.

Conditions: Insulin Resistance; Age Problems

Summary: this study intends to examine the effect of a commercially available nutritional supplement, beta-hydroxy-beta-methylbutyrate(hmb) on whole-body responses to a sugar load.

one change associated with human aging is a reduction in "fitness", both in terms of how far or quickly a person can run/cycle/swim and also in how well their blood vessels work. additionally a person's metabolic fitness decreases; this is how well the body copes with nutrition and is why, for example, older people have a higher risk of diseases like type 2 diabetes. previous studies have shown that as people become less fit, they are at increased risk of suffering a complication whilst undergoing surgery. it has also been shown that measuring how fit someone is, is better at predicting the risk of a surgical complication than purely using a person's age alone. lots of research has shown that exercise can potentially reverse some of the age-related declines in fitness, however most has used long sessions of continuous exercise over a long period of time. high-intensity interval training (hit), whereby people cycle on an exercise bike very hard for a minute, followed by a short rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. however not everyone will be able to, or indeed want to participate in exercise this strenuous; therefore this research seeks to explore whether other options, such as dietary supplements can improve aspects of fitness this study intends to examine the effect of giving a dietary supplement on the way a person's body handles the glucose (from carbohydrates/ sugars) in a meal. previous work has shown that taking a beta-hydroxy beta-methyl butyrate (hmb) supplement may improve may improve a patient's response to glucose, however the evidence is not clear. hmb is a commercially available nutritional supplement providing a compound that the body produces each time protein is consumed, and is most commonly used by bodybuilders to help gain muscle.

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-35 or 65-85 * male exclusion criteria: * current participation in a formal exercise regime * a bmi \ 32 kg·m2 * active cardiovascular disease: o uncontrolled hypertension (bp \> 160/100), angina, heart failure (class iii/iv), significant arrhythmia, right to left cardiac shunt, recent cardiac event * taking beta-adrenergic blocking agents, * cerebrovascular disease: o previous stroke, aneurysm (large vessel or intracranial), epilepsy * respiratory disease including: o pulmonary hypertension, significant copd, uncontrolled asthma, * metabolic disease: o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, cushing's disease, type 1 or 2 diabetes * active inflammatory bowel or renal disease * malignancy * clotting dysfunction * significant musculoskeletal or neurological disorders * family history of early (\<55y) death from cardiovascular disease
effectiveness of online systematic brief psychodynamic psychotherapy for neurotic disorders: randomized controlled trial

Conditions: Neurotic Disorders

Summary: objective: to evaluate the effectiveness of online systematic brief psychodynamic psychotherapy (sbpp) via hipaa compliant web conferencing on adults with neurotic disorders. design: randomized controlled trial. single blind. setting: internet users in the community, in são paulo, brazil. participants: thirty-two adults will be randomly allocated to a group will receive online systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16). method: systematic adaptative diagnosis system will be applied in both groups at pre-treatment and post-treatment (or post-waiting list). assessment will be a comparison of the adaptative diagnosis evolution between groups. primary outcomes: the subjects treated with online brief systematic psychodynamic psychotherapy will present an increase in their adaptative efficacy measured by systematic adaptative diagnosis scale (sads) in comparison to the waiting list group, when contrasting their initial and final adaptative diagnostics.


Eligibility criteria:
inclusion criteria: * residents in sao paulo city, * graduation complete or in course, * fluent portuguese, * basic skills on english language, * if in psychiatric treatment, must be under treatment with stable dosage of psychiatric medication for at least 6 months, * participants with diagnosis of neurotic disorders (f03.650), * motivation for the therapeutic process, * availability for 4 months of psychotherapy, * a personal computer (with an ip address), a web camera, a microphone, access to a 1 mbps internet connection and specific computer configuration to access the secure psychotherapy virtual environment, * basic knowledge of elementary internet tools, * a justified reason that impedes a in person psychotherapy, such as the ones below: * lack of financial resources, * frequent change of address due to work reasons, * mobility restrictions related to accidents, illnesses or physical deficiencies, * inability to arrive for psychotherapy appointments due to urban chaos. exclusion criteria: participants that present: * a schizophrenia diagnostic or any other severe mental illness, * drug and alcohol dependence that are in abstinence from substance abuse, * untreated diagnosis of illnesses that may cause emotional imbalance, such as thyroid malfunction, * participants that are undergoing a therapeutic process during the time of the research, * individuals with both suicidal ideation and clear intent and need emergency treatment, * participants do not possess the characteristics needed to be included in the sample or are bearers of deficiencies that may compromise the treatment mediated by a computer.

Keywords: psychoanalytic psychotherapy telepsychology online therapy web conferencing rct hipaa